Spinal Vascular Disorder NosNCT03280316
Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery
A study testing surgery, sacral neuromodulation and botulinum toxin A injection in people with Spinal Vascular Disorder Nos and Overactive Bladder, run by Xuanwu Hospital, Beijing.
Trial summary
The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Vascular Disorder Nos, Overactive Bladder
- What is being tested?
- surgery, sacral neuromodulation and botulinum toxin A injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.
- patient not received surgical or interventional treatment before
- patient with normal cardiac, renal and hepatic function
- patient capable of understanding the content of the patient information / Informed Consent Form
- patient willing and able to participate in the registry
- patients have consistent OAB after surgery
Who cannot join
- •patient received surgical treatment or interventional treatment before
- patient is pregnant
- patient allergic to iodine
- patient unable to complete follow-up
- patient with cerebral lesions
- patient with other spinal lesions
- patient with cardiac, renal or hepatic dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery
The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.
Read the detailed description
Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB (Overactive Bladder) in patients with SVMs after surgery.
- Conditions
- Spinal Vascular Disorder Nos, Overactive Bladder
- Being tested
- surgery, sacral neuromodulation, botulinum toxin A injection, M receptor antagonist
- Keywords
- Spinal Vascular Disorder, Overactive Bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
patients with SVMs receive surgery
sacral neuromodulationProcedure or surgery
sacral neuromodulation (SNM) with InterStimTM
botulinum toxin A injectionProcedure or surgery
BOTOX
M receptor antagonistDrug
Also called Tolterodine
Tolterodine
| Study group | Role | What they receive |
|---|---|---|
| patients with SVMs undergoing SNM | Experimental | patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM) Receives: Procedure: surgery; Procedure: sacral neuromodulation |
| patients with SVMs receiving BTXA | Experimental | patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection Receives: Procedure: surgery; Procedure: botulinum toxin A injection |
| patients with SVMs receiving drug | Experimental | patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist Receives: Procedure: surgery; Drug: M receptor antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder function
bladder function change in urodynamics
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startJan 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Vascular Disorder NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ou tongwen, Xuanwu Hospital, Beijing
- Investigators
- tongwen ou, M.D, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280316
- Sponsor's protocol ID
- otw-20170909
- Status last verified
- Apr 2020
- First submitted
- 8 Sep 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery
- ClinicalTrials.gov ID
- NCT03280316
- Acronym / sponsor ID
- otw-20170909
- Conditions
- Spinal Vascular Disorder Nos, Overactive Bladder
- Keywords
- Spinal Vascular Disorder, Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.
Detailed description
Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB (Overactive Bladder) in patients with SVMs after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with SVMs undergoing SNM | Experimental | Procedure: surgery, Procedure: sacral neuromodulationpatients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM) |
| patients with SVMs receiving BTXA | Experimental | Procedure: surgery, Procedure: botulinum toxin A injectionpatients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection |
| patients with SVMs receiving drug | Experimental | Procedure: surgery, Drug: M receptor antagonistpatients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- •Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.
Key exclusion criteria (7 listed)
- •patient received surgical treatment or interventional treatment before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgerypatients with SVMs receive surgery | Procedure or surgery | patients with SVMs receiving BTXA, patients with SVMs receiving drug, patients with SVMs undergoing SNM |
| sacral neuromodulationsacral neuromodulation (SNM) with InterStimTM | Procedure or surgery | patients with SVMs undergoing SNM |
| botulinum toxin A injectionBOTOX | Procedure or surgery | patients with SVMs receiving BTXA |
| M receptor antagonistAlso: TolterodineTolterodine | Drug | patients with SVMs receiving drug |
Primary outcome
bladder function
Time frame: 3 months and 12 months
bladder function change in urodynamics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tongwen ou, M.D study director
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing surgery, sacral neuromodulation and botulinum toxin A injection in people with Spinal Vascular Disorder Nos and Overactive Bladder, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhenhua shang, M.D (17801117318, shangzhenhua16@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder function (time frame: 3 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.